Strategies Using Darbepoetin Alfa to Avoid Transfusions in Chronic Kidney Disease (START-CKD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01652872
First received: June 7, 2012
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

A phase 3, multicenter, randomized, double-blind, parallel group study. Anemic subjects with chronic kidney disease and not on dialysis will be randomized 1:1 to 1 of 2 dosing strategies to evaluate the proportion of subjects receiving at least one red blood cell transfusion. In the Hb-based titration group, darbepoetin alfa doses will be titrated to maintain hemoglobin (Hb) ≥ 10.0 g/dL. In the fixed dose group, subjects will receive a fixed dose of darbepoetin alfa. Treatment group, darbepoetin alfa doses, and protocol specified Hb concentrations will be blinded. Subjects will be followed for approximately 2 years from the date of randomization.


Condition Intervention Phase
Management of Anemia in Chronic Kidney Disease Patients Not on Dialysis.
Biological: Darbepoetin alfa
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Strategies Using Darbepoetin Alfa to Avoid Transfusions in Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Receipt of 1 or more RBC transfusion [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total number of units of red blood cells (RBC) transfused. Time to first red blood cell transfusion. [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]
  • Average achieved hemoglobin (Hb) concentration while receiving investigational product. [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Cumulative dose of darbepoetin alfa [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Time to first RBC transfusion [ Time Frame: From randomization to the first RBC transfusion ] [ Designated as safety issue: No ]

Estimated Enrollment: 750
Study Start Date: July 2011
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hemoglobin Based Titration Group
Subjects randomized to the hemoglobin based titration group will have their dose of investigational product titrated based on the hemoglobin concentration on the date of the visit, the corresponding hemoglobin rate of rise, and the previously assigned dose.
Biological: Darbepoetin alfa
Darbepoetin alfa will be presented as single use prefilled syringes. Investigational product will be administered subcutaneously every 4 weeks for the duration of the treatment period.
Active Comparator: Fixed Dose Group
Subjects randomized to the fixed dose group will receive the same dose as the one assigned at the time of randomization for the duration of the treatment period with one exception: if the hemoglobin is > 12.0 g/dL, darbepoetin alfa therapy will be withheld until the hemoglobin falls below 10.0 g/dL.
Biological: Darbepoetin alfa
Darbepoetin alfa will be presented as single use prefilled syringes. Investigational product will be administered subcutaneously every 4 weeks for the duration of the treatment period.

Detailed Description:

The study is a phase 3, multicenter, randomized, double-blind, parallel group study designed to describe the benefits and potential risks of a new treatment strategy using a fixed dose of darbepoetin alfa in subjects with chronic kidney disease and not on dialysis. Anemic subjects without recent use of an erythropoiesis stimulating agent (ESA) will be randomly allocated 1:1 to treatment with a fixed dose of darbepoetin alfa or to treatment with darbepoetin alfa using a hemoglobin (Hb)-based titration strategy, which has been the conventional dosing strategy. In the Hb-based titration group, darbepoetin alfa doses will be titrated to maintain hemoglobin (Hb) ≥ 10.0 g/dL. This study aims to estimate the incidence of red blood cell (RBC) transfusions (administered as deemed clinically necessary) in each group and the difference in incidence of RBC transfusions between the 2 groups. In addition, multiple aspects, such as cumulative darbepoetin alfa dose, total number of units of transfusions, Hb concentration, Hb-related parameters (eg, Hb variability, excursions, rate of change), and adverse (eg, cardiovascular) events, will also be considered in order to determine a preferred dosing regimen. Treatment group, darbepoetin alfa doses, and protocol specified Hb concentrations will be blinded to the investigator, subjects and study team. Subjects will be followed for approximately 2 years from the date of randomization.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Hb concentration < 10.0 g/dL
  • Estimated glomerular filtration rate of < 45.0 mL/min/1.73m2
  • Transferrin saturation (TSAT) ≥ 20% and ferritin ≥ 100 ng/mL
  • Clinically stable by the investigator

Key Exclusion Criteria:

  • Received erythropoiesis stimulating agents (ESAs) within 4 weeks of screening
  • Received a red blood cell transfusion within 8 weeks of screening
  • Received intravenous iron or had changes to oral iron therapy within 4 weeks of screening
  • Uncontrolled hypertension, defined in this study, as a mean systolic blood pressure > 140 mmHg at both screening visits, or a mean systolic blood pressure >/= 160 mmHg at any screening visit, or a mean diastolic blood pressure >/= 90 mmHg at any screening visit.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01652872

Contacts
Contact: Amgen Call Center 866-572-6436

  Show 251 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01652872     History of Changes
Other Study ID Numbers: 20110226
Study First Received: June 7, 2012
Last Updated: August 6, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Amgen:
anemia
chronic kidney disease
kidney disease
renal failure

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014